Details for New Drug Application (NDA): 212266
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The generic ingredient in CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY is cetirizine hydrochloride. There are thirty-nine drug master file entries for this compound. One hundred and fifty-seven suppliers are listed for this compound. Additional details are available on the cetirizine hydrochloride profile page.
Summary for 212266
Tradename: | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY |
Applicant: | Quagen |
Ingredient: | cetirizine hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 212266
Mechanism of Action | Histamine H1 Receptor Antagonists |
Medical Subject Heading (MeSH) Categories for 212266
Suppliers and Packaging for NDA: 212266
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | cetirizine hydrochloride | SOLUTION;ORAL | 212266 | ANDA | QUAGEN PHARMACEUTICALS LLC | 70752-103 | 70752-103-06 | 1 BOTTLE, PLASTIC in 1 CARTON (70752-103-06) / 118 mL in 1 BOTTLE, PLASTIC |
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | cetirizine hydrochloride | SOLUTION;ORAL | 212266 | ANDA | QUAGEN PHARMACEUTICALS LLC | 70752-104 | 70752-104-06 | 1 BOTTLE, PLASTIC in 1 CARTON (70752-104-06) / 118 mL in 1 BOTTLE, PLASTIC |
Profile for product number 001
Active Rx/OTC/Discontinued: | OTC | Dosage: | SOLUTION;ORAL | Strength | 5MG/5ML | ||||
Approval Date: | May 16, 2019 | TE: | RLD: | No |
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